SORAGO-HCC: Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment

Sponsor

Bayer (Industry)

Overall Status

Terminated

CT.gov ID

NCT03644511

Collaborator

(none)

Enrollment

Location

8.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).

In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Sorafenib (Nexavar, BAY43-9006)

Study Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment

Actual Study Start Date :

Jan 24, 2019

Actual Primary Completion Date :

Jul 18, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with HCC Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment	Drug: Regorafenib (Stivarga, BAY73-4506) Prescribed by physician. Drug: Sorafenib (Nexavar, BAY43-9006) Prescribed by physician.

Arm

Intervention/Treatment

Patients with HCC

Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment

Drug: Regorafenib (Stivarga, BAY73-4506)

Prescribed by physician.

Drug: Sorafenib (Nexavar, BAY43-9006)

Prescribed by physician.

Outcome Measures

Primary Outcome Measures

Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions [Up to 24 months]

Secondary Outcome Measures

Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy [Up to 36 months]
Progression free survival (PFS) [Up to 36 months]
Time to progression (TTP) [Up to 36 months]
Duration of Nexavar or Stivarga treatment [Up to 36 months]
Tumor response to treatment [Up to 36 months]
Evaluated by the investigator according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable", and will be analyzed providing absolute and relative frequencies of the tumor status categories.
Incidence of treatment-emergent adverse events (TEAE) [Up to 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C
Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.

Exclusion Criteria:

Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice.
Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug.
Contra-indications according to the local marketing authorization.